Kornimate/medical-research-clean huggingface dataset:
safety, tolerability and pharmacokinetics of onc1-0013b in patients with progressive metastatic castration-resistant prostate cancer

Conditions: Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Summary: this is a phasei, open-label study, dose-escalation study, where tolerated doses will be escalated to the next doses with the safety, tolerability, and pk being evaluated in metastatic castration-resistant prostate cancer (mcrpc) patients. tumor assessment and psa values will be evaluated during the study as an additional point.


Eligibility criteria:
inclusion criteria: 1. men aged 18 years and older. 2. histologically confirmed diagnosis of prostate cancer 3. castrate level of testosterone in blood serum \< 1,7 nmol/l or \< 50 ng/dl 4. psa level at screening \> 2 ng/ml 5. progression of metastatic crpc after the chemical castration with gonadotropin-releasing hormone (gnrh) analogue or after the chemical castration and subsequent chemotherapy. 6. the patient's ecog performance status of 0 - 2 7. patients previously treated with docetaxel chemotherapy should have received 2 or less prior lines of chemotherapy for mcrpc 8. the expected survival time of not less than 12 weeks exclusion criteria: 1. prior anticancer therapy: * treatment with chemotherapeutic agents or radiotherapy within 4 weeks prior to screening or preserved toxicities of ≥ ii grade according to ctcae scale, related to prior anticancer therapy (excluding alopecia) * prior antiandrogen therapy: flutamide within 4 weeks prior to screening or bicalutamide within 6 weeks prior to screening * exposure to bisphosphonates is allowed only if the treatment started prior to screening 2. clinically significant cardiovascular system diseases: 3. clinically significant central nervous system diseases: 4. history of other significant concomitant diseases which, in the investigator's opinion, may cause a disease recurrence (i.e. uncontrolled diabetes mellitus) 5. prior or concomitant therapy: * exposure to drugs which may cause a convulsive state within 4 weeks prior to screening * exposure to treatment with characteristics of cyp3a4 or cyp2d6 inhibitors within 4 weeks prior to screening * exposure to treatment relating to the class i risk of qt-interval prolongation; exposure to treatment relating to the class ii risk of qt-interval prolongation is allowed if the patient have received not less than 5 half-life periods of flat-dosed treatment
mhealth for art adherence by hiv+ african americans

Conditions: HIV-1-infection

Summary: the objective of this grant is to create and test a mobile app to support art adherence among hiv+ african american adults.

the phase ii project will enhance the existing (phase 1) mobile intervention by offering: 1) a two-way communication capability through which participants can: i) indicate "pill taken" in response to pill reminders, and ii) receive a positive visual icon as behavioral-economics based reinforcement for "pill taken" responses; 2) pharmacist counseling and medication support; and, 3) the addition of educational and motivational text messages. overall aims are to: 1) expand mhealth intervention to incorporate new phase ii features; 2) evaluate effectiveness in an rct of hiv+ african americans; and 3) prepare marketing and commercialization plans. our long-term goal is to increase art medication adherence, thus decreasing health disparities, among hiv+, african-americans.

Eligibility criteria:
inclusion criteria: (a) self-identify as african american, (b) age 30 or older, (c) hiv positive (d) currently on art (e) report having problems with, and interest in improving their art adherence (f) own a smartphone (g) report english as their primary language - exclusion criteria: (a) not self-identified as african american, (b) under age 30 (c) hiv negative (d) not currently on art (e) do not report having problems with, or interest in, improving their art adherence (f) do not own a smartphone (g) do not report english as a primary language and (h) participating in another research study or clinical trial (i) receiving care at non-participating site and, (j) dementia diagnosis. -
decreasing loneliness to optimize pain care

Conditions: Loneliness; Opioid Use

Summary: loneliness, which is the perceived feeling of insufficient personal relationships, is related to higher risk for inappropriate opioid use and opioid use disorders in patients who are taking opioids long-term. the study seeks to pilot test the evidence-based loneliness interventions of psychological therapy and social navigation in patients on chronic opioids treated in primary care practices to determine if reducing loneliness can lower opioid misuse.

patients with chronic pain on opioids frequently experience loneliness, which is associated with poorer health outcomes and higher risks for opioid misuse and opioid use disorder. given that almost half of opioids are prescribed in primary care, a critical need exists for the development and testing of interventions to reduce loneliness in primary care patients at risk for opioid misuse. the long-term goal of the study is to reduce opioid misuse and opioid use disorder by addressing loneliness in primary care with patients on chronic opioids. interventions addressing maladaptive social cognition through cognitive behavioral therapy and improving social support through social navigation have been shown to be effective in reducing loneliness and improving outcomes in other fields but have not been tested in patients at risk for substance use disorder. aims * to refine both the social navigation and psychological cbt loneliness interventions for patients in primary care on chronic opioids * to assess the feasibility of implementing a 3-arm pilot randomized clinical effectiveness trial testing a psychological cbt and a social navigation intervention to address loneliness in primary care patients. * to determine the distribution and variability in the mediating outcome (loneliness), the primary outcome (opioid misuse) and secondary outcomes, including opioid dose, functional status and patient-reported pain outcomes in the pilot randomized clinical effectiveness trial.

Eligibility criteria:
inclusion criteria: * 18 years or older * english-speaking * on chronic opioids (defined as defined as 3 or more months receiving prescribed opioids \[functional definition is 3 or more opioid prescriptions each less than 21 days apart as per our prior studies\]) * with a score greater or equal to 6 on the ucla loneliness 3-item scale * have a chronic pain diagnosis exclusion criteria: * have cancer-related pain * are on palliative care or live in a controlled setting (i.e., assisted living, nursing home or inpatient treatment facility) * have an upcoming scheduled surgery * severe cognitive impairment or active psychosis

Keywords: loneliness opioid use chronic pain
temporal immunologic changes with hypofractionated radiation-induced dna damage in breast cancer

Conditions: Breast Carcinoma; Invasive Breast Carcinoma

Summary: this study assesses changes to the immune cells following hypofractionated radiation-induced dna damage in breast cancer patients. radiation therapy may cause immune cells to enter tumors and target cancer cells. the goal of this study is to measure the change in the level of immune cells in the tumor before and after radiation therapy.

primary objective: i. to estimate the percent change in immune infiltration at day 3 and day 7 of radiotherapy (rt) relative to baseline (before radiotherapy). secondary objective: i. to estimate the degree of deoxyribonucleic acid (dna) damage at approximately 3 and 7 days after radiotherapy compared to baseline. ii. to examine cancer cell intrinsic immune signaling following radiotherapy. exploratory objective: i. to examine the association between dna damage and micronuclei formation. ii. to examine the association between dna damage and immune infiltration. iii. to examine the association between micronuclei formation and immune infiltration. outline: patients undergo rt on day 1. patients also undergo tumor punch biopsies and blood sample collection prior to the first fraction and on days 1, 3, and 7.

Eligibility criteria:
inclusion criteria: * patients \>= 18 years of age with biopsy proven invasive breast cancer * breast cancer that appears to be superficially accessible to a tumor punch biopsy * patients thought to derive clinical benefit from palliative rt to the breast/chestwall * in discussions with the medical oncologist, if clinically reasonable, systemic therapy will be held during rt exclusion criteria: * a history of prior radiation to the area requiring radiation for which the attending physician believes reirradiation could not be safely delivered * pregnancy * active usage of anticoagulant medications that are considered to pose an increased risk of tumor punch biopsies * receipt of immunotherapy or chemotherapy 7 days prior to start of rt
vnrx-5133 drug-drug interaction in healthy adult volunteers

Conditions: Bacterial Infections

Summary: this is a 2-part, drug-drug interaction study to evaluate potential pk interactions after single doses in part 1 and multiple doses in part 2. in part 1, subjects will receive single dose of 5 treatments in a cross-over design; in part 2 subjects will receive treatment for 10 days.


Eligibility criteria:
inclusion criteria: * healthy adults * males or non-pregnant, non-lactating females * body mass index (bmi) between 18.5 - 32.0, inclusive * weight greater than or equal to 50 kg * suitable veins for cannulation exclusion criteria: * employee of site or the sponsor * any disease that poses an unacceptable risk to participants * abnormal ecg * abnormal labs * abnormal vital signs * current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, autoimmune, hematologic, neoplastic, or neurological disorder * positive serology for hepatitis b surface antigen, hepatitis c antibody, or human immunodeficiency virus (hiv) type 1

Keywords: healthy volunteers pharmacokinetics
mobile-thrive - a family self-management approach to failure to thrive

Conditions: Failure to Thrive

Summary: failure to thrive negatively affects growth, cognition, behavior, and quality of life (qol), which can be devastating and enduring. these outcomes are high-cost and lead to increased family stress and negatively affect the caregiver-child relationship. therefore, families need increased access to materials that will help them understand their child's health and help them use new feeding behaviors to improve the child's nutrition and growth. standard care with the addition of mobile thrive (m-thrive), our innovative smart phone-based mobile app, is intended to demonstrate the clinical advantages of using mobile health technology (mhealth) in comparison to standard care alone.

families will be randomly assigned to either the standard care plus access to the mobile-thrive (m-thrive) application or standard care alone. all families will complete a 24-hour dietary recall, feeding strategies questionnaire (fsq), pedsql family impact module (pedsql fim), and pediatric inventory for parents (pip) at pre/post treatment. it will take about 45 minutes to complete these measures. anthropometric measurements will be collected at pretreatment, 6 weeks, and 3 months. families receiving standard care alone will have regularly scheduled visits in the nutritional care program and will have access to standard care resources, including phone contacts and electronic access through the chw hospital portal. specifically, standard care treatment provides dietary and behavioral instructions on appropriate beverage intake, appropriate feeding regimen, advice on limiting low-calorie foods, and multivitamin supplementation, if appropriate. families in the standard care plus the m-thrive application will receive the standard care treatment that is described above, as well as on-demand resources, daily educational text messages, and family self-management push notifications through the m-thrive application. the research team will train families on the use of the m-thrive application and families in the standard care plus m-thrive application can contact their provider through the application with questions and/or concerns. at the conclusion of the intervention, qualitative data regarding the participants' experience will be collected. specifically, 90-minute focus group sessions will occur within 2 weeks of concluding the 3 month active phase of treatment. families will be asked to discuss factors that affected their ability to sustain condition management recommendations, their efforts to access health care resources, factors that affect family quality of life and caregiver stress, and family impressions of what else would help to build support for families managing ftt. all sessions will be transcribed and coded for content analysis.

Eligibility criteria:
inclusion criteria: * parents of children ages 4 months to 4 years old with a medical diagnosis of failure to thrive. * english speaking. exclusion criteria: * parents of children who do not meet the inclusion criteria. * non- english speaking.
eras in gastrointerstinal fistulas.

Conditions: Fistula; Surgery Site Fistula

Summary: an enterocutaneous fistula (ecf) poses a major surgical problem. the definitive surgical repair of persistent fistulas remains a surgical challenge with a high rate of re-fistulation and mortality, and the reasons for that is not the surgical technique alone. enhanced recovery after surgery (eras®) is an evidence-based multimodal perioperative protocol proven to reduce postoperative complications. the aim of the study was to assess the clinical value of eras protocol in surgical patients with ecf.

eras protocol was used in all patients scheduled for surgery for ecf at the stanley dudrick's memorial hospital in skawina between 2011 and 2020. a multidisciplinary team (mdt) was in charge of the program and performed annual audits. a consecutive series of 100 ecf patients (44 f, 56 m, mean age 54.1) was evaluated. postoperative complications rate, readmission rate, length of hospital stay, prevalence of postoperative nausea and vomiting were assessed.

Eligibility criteria:
inclusion criteria: * surgery for gastrointestinal fistula exclusion criteria: * conservative treatment
risk analysis of cardiotoxic medication use due to sodium arsenite chloride injection

Conditions: Adverse Reaction; Cardiotoxicity; Evaluation Study

Summary: to study the current status of cardiotoxicity of arsenious acid by analyzing the literature, monitoring data, and real-world applications, and to discuss risk factors and preventive and control measures.

through the project study, the risk rate of cardiotoxicity caused by arsenious acid will be verified and evaluated, and a typical case analysis will be conducted to assess the risk and benefit ratio of clinical use of arsenious acid injection and to formulate preventive measures, so as to guide the holder of the marketing authorization to carry out in-depth safety studies and to ensure the public's safe use of the drug.

Eligibility criteria:
inclusion criteria: * the period of consultation (for inpatients, according to the time of admission) is from january 1, 2012 to december 31, 2022 * the patient used arsenite sodium chloride injection exclusion criteria: * patients with incomplete clinical information

Keywords: arsenious acid arsenic trioxide cardiotoxicity
natural history study of infants and children with developmental and epileptic encephalopathies

Conditions: Dravet Syndrome

Summary: this is a multicenter, prospective, 2-year observational study in infants and children with developmental and epileptic encephalopathies (dees). the dee currently being investigated is scn1a-positive dravet syndrome.

this prospective, longitudinal, natural history master protocol has been designed to define the seizure, neurodevelopmental, and behavioral characteristics of scn1a-positive dravet syndrome in infants and children between 6 and 60 months. it will also explore the impact of the disease on the participant's parent/caregiver quality of life (qol) and healthcare resource utilization (hcru).

Eligibility criteria:
inclusion criteria: * aged between 6 months and 60 months. * confirmed scn1a mutation. * normal development prior to onset of first seizure as defined by the centers for disease -control and prevention (cdc 2019). * onset of seizures between age 3 and 15 months, inclusive. exclusion criteria: * copy number variant of scn1a, including scn1a microdeletion, if affecting other genes. * scn1a mutation present on both alleles. * known pathogenic or clinically suspected mutation in a seizure-associated gene besides scn1a. * confirmed mutation in a gene besides scn1a that is known to increase the severity of the seizure phenotype. * known gain-of-function genetic mutation, as defined by functional studies, including p.thr226met. * history of notable developmental deficit that was evident prior to seizure onset. * known central nervous system structural abnormality as found on magnetic resonance imaging or computed tomography scan of brain. * currently taking or has taken for 6 or more consecutive weeks anti-seizure medications (asms) at a therapeutic dose that are contraindicated in scn1a-positive dravet syndrome, including sodium channel blockers. * known concomitant genetic mutation or clinical comorbidity that potentially confounds typical dravet phenotype.

Keywords: severe myoclonic epilepsy epilepsy severe myoclonic epilepsy of infancy smei scn1a related seizure disorder epileptic encephalopathy developmental and epileptic encephalopathies dee
using adhesive biosensor patches to characterize the biochemical phenotype in ptsd

Conditions: Post Traumatic Stress Disorder

Summary: a psychiatric diagnosis of post-traumatic stress disorder (ptsd) is currently based mainly on non-quantitative elements, such as interviews and subjective impressions. ptsd has physiological manifestations, some of which are likely reflected in the levels and ratios of certain stress-related proteins in the interstitial fluid and plasma. discernable patterns of such stress-related proteins may constitute a biochemical phenotype characteristic of ptsd, which may serve as a biomarker and support diagnostic decisions, as well as personalized treatment plans. the current study is a non-interventional observational study aimed at examining the possibility of basing a psychiatric diagnosis by measuring changes in the biochemical phenotype of participants with ptsd.


Eligibility criteria:
inclusion criteria: * ptsd diagnosis (excluding controls) * proper ability to give informed consent exclusion criteria: * active psychotic or suicidal symptoms * active/terminal oncological condition * dialysis patients * pregnancy
observational study in patients with hiv infection type 1 after switching to a viramune®-containing therapy regimen

Conditions: HIV Infections

Summary: observational study to collect data on maintaining anti-retroviral activity (quantitative hiv rna determination) and immunological activity (cd4 cells) despite switching from protease inhibitor to nonnucleoside reverse transcriptase inhibitor (nnrti) (viramune®).


Eligibility criteria:
inclusion criteria: * adult male or female patients with hiv type 1 infection exclusion criteria: * counter-indications according to summary of product characteristics (spc) for viramune tablets * no persons under 18 * pregnancy and breast-feeding * use of oral contraceptives * use of drugs affecting cyp450 3a metabolism
extracorporal shockwave lithotripsy versus retrograde intrarenal surgery for the treatment of kidney stones

Conditions: Kidney Stones

Summary: the purpose of this study is to compare two established modalities for the treatment of kidneystones: eswl (extracorporal shockwave-lithotripsy) vs. urs (uretero-reno-scopy with stone-extraction). comparison of the stone-free rates 3month postoperative. * trial with surgical intervention


Eligibility criteria:
inclusion criteria: - kidneystones requiring treatment up to an maximal size of 15mm (singular or multiple kidneystones with at least one stone with min. 5mm of size) * male and female patients between 18 and 99 years * informed consent signed by patient after explanation of the both treatment-modalities exclusion criteria: - age \ 99 * pregnancy * breastfeeding mother * disorders of blood clotting * kidneystones \> 15mm * aneurysms of the aorta or renal artery * severe skeletal deformations which hamper one of the treatment modalities * synchronous stones of the ipsilateral ureter * stones which can not visualized which x-ray or sonography
capacity to consent in acutely intoxicated emergency department patients

Conditions: Informed Consent

Summary: the ability to meaningfully consent intoxicated and chemically dependent patients for research has inhibited medical advances in this vulnerable population. a recent pilot supported use of the university of california, san diego brief assessment of capacity to consent tool to assess the capacity of intoxicated emergency department patients to participate in research. the objective is to determine the number of intoxicated emergency department patients who could correctly complete the questionnaire, and evaluate alcohol concentration, sedation and ability to recall participation upon sobriety.


Eligibility criteria:
inclusion criteria: * 18 years or older, intoxicated with alcohol exclusion criteria: * intoxication was due to a substance other than ethanol (negative breath alcohol concentration), refusal to participate, excessive agitation, or if the treating physician deemed the patient medically or psychologically unstable. patients were also excluded if they had previously been enrolled in the study

Keywords: alcohol
microbiome analysis of constipated versus non-constipation patients

Conditions: Rome IV Functional Constipation

Summary: this study intends to evaluate the microbiome of chronically constipated patients as compared to those with a non-constipated gastrointestinal system.

biogeographically accurate microbiome sampling using the hygieacare platform and an evolutionary biology informed learning platform will allow an improved discovery of bacterially derived novel molecular entities with therapeutic potential for chronic constipation. this approach intends to enhance our ability to understand the gut microbiome and use it towards developing therapeutic solutions, in comparison to traditional collection methods and taxonomic-based data analysis approaches.

Eligibility criteria:
inclusion criteria: 1. patient's age is between 18 and 80 years old. 2. for the healthy population - indication for age-appropriate colorectal cancer screening colonoscopy 3. adequate capacity to consent to study 4. patient does not have any known health issues, except for chronic constipation for the "chronic constipation" population. 5. patient has not taken antibiotics within the last three (3) months. 6. for chronically constipated patients - \>3 months of symptomatic constipation with first onset of constipation more than 6 months ago. for chronically constipated patients - diagnosis of functional constipation by modified rome iv diagnostic criteria. exclusion criteria: 1. patient has functional bowel disorders characterized by alternating bowel habits (diarrhea/constipation). 2. patient has any other condition that, in the opinion of the investigator, may adversely affect the compliance or safety of the patient or would limit the patient's ability to complete the study. 3. current, or recent (within three months) antibiotic usage patient has any of the contraindications listed below: 4. cardiac: congestive heart failure (nyha class iii or iv or ef \<50%) 5. gi: intestinal perforation, carcinoma of the rectum, fissures or fistula, severe hemorrhoids, abdominal hernia, recent colon or rectal surgery, or abdominal surgery 6. gu: renal insufficiency (cc \< 60 ml/min/173m2), cirrhosis with ascites 7. abdominal surgery within the last 6 months 8. pregnancy